A Study of Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) Combination Therapy in Participants With Chronic Hepatitis C (CHC) and Various Degrees of Renal Impairment

Hepatitis C, Chronic Clinical Trial

Official title:

Non-Randomized, Multicenter Study to Evaluate the Pharmacokinetics and Safety of Peginterferon Alfa-2a and Copegus Combination Therapy After Single and Multiple Doses in Patients With Chronic Hepatitis C and Moderate Renal Impairment, Severe Renal Impairment, or End-Stage Renal Disease Undergoing Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02864199
• Other study ID #: NP17355
• Status: Completed
• Phase: Phase 4
• First received: August 9, 2016
• Last updated: August 9, 2016
• Start date: February 2004
• Est. completion date: September 2007

Study information

• Verified date: August 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the pharmacokinetics (area under the curve [AUC], maximum concentration [Cmax], and other parameters) and tolerability of peginterferon alfa-2a and ribavirin combination therapy following single and multiple doses in participants with CHC infection and moderate to severe renal impairment or end-stage renal disease (ESRD) receiving hemodialysis. The anticipated time on study treatment is up to 48 weeks, and the target sample size is 48 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Adults 18 to 65 years of age

• CHC infection as shown on enzyme-linked immunosorbent assay (ELISA) and radioimmunoblot assay (RIBA) or quantifiable hepatitis C virus (HCV) ribonucleic acid (RNA) greater than (>) 2000 copies per milliliter (copies/mL)

• Use of two forms of contraception during study and 6 months after the study in both men and women

• Normal renal function (creatinine clearance [CrCl] >80 milliliters per minute [mL/min]), moderate renal impairment (CrCl 30 to 50 mL/min), severe renal impairment (CrCl less than [<] 30 mL/min), or ESRD requiring hemodialysis

• Patients with ESRD must have been undergoing hemodialysis for at least 2 months

Exclusion Criteria:

• Women who are pregnant or breastfeeding

• Male partners of women who are pregnant

• Conditions associated with decompensated and/or chronic liver disease

• Human immunodeficiency virus (HIV) infection

• Interferon or ribavirin treatment within the previous 3 months

• Poor hematologic function, including unstable hemoglobin

• Significant comorbidity or severe illness which would make the participant unsuitable for the study

• Acute renal failure

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Renal Insufficiency

Intervention

Drug:
• Peginterferon alfa-2a
Peginterferon alfa-2a will be administered for 12 to 48 weeks. The dose will range from 135 mcg (Group C) to 180 mcg (Groups A, B, and D) once weekly via SC route.
• Ribavirin
Ribavirin will be administered for 12 to 48 weeks. The total daily dosage will range from 200 mg (Group C) to 1200 mg (Group D), depending upon CrCl and participant-specific factors.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Brazil,  France,  New Zealand,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of peginterferon alfa-2a		Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12	No
Primary	CL/F of ribavirin		Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12	No
Primary	Percentage of participants with undetectable HCV RNA level		Week 12	No
Primary	Cmax of ribavirin		Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12	No
Primary	AUC of ribavirin		Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12	No
Primary	AUC of peginterferon alfa-2a		Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12	No
Primary	Clearance (CL/F) of peginterferon alfa-2a		Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12	No
Secondary	Time of maximum concentration (Tmax) of peginterferon alfa-2a		Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12	No
Secondary	Tmax of ribavirin		Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12	No
Secondary	Plasma concentration of ribavirin		Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12	No
Secondary	Percentage of participants with adverse events (AEs)		From Baseline to Week 12 (or up to Week 48 if treatment continued)	No
Secondary	Percentage of participants with a dose modification or premature withdrawal for safety reasons		From Baseline to Week 12 (or up to Week 48 if treatment continued)	No